Diffuse Large B-Cell Lymphoma (DLBCL)NCT04624893
A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin
An observational study of Diffuse Large B-Cell Lymphoma (DLBCL), run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
To assess the clinical outcomes following treatment with Pola in combination with Bendamustine, Rituximab (BR) or Rituximab (R) in patients with R/R DLBCL who are not eligible for transplantation in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- Polatuzumab Vedotin-Piiq
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients enrolled in the Pola CUP program in China
Who may be able to join
- Hospitalized patients Patients who enrolled in the Pola CUP program and met the following criteria:
- Histologically confirmed DLBCL, patients have exhausted all therapeutic options for DLBCL and have been treated with at least two prior lines of therapy including R-CHOP (or similar regimen for 1L DLBCL)
- Not considered to be eligible for Bone Marrow Transplantation (BMT) (both allogenic or autologous)
- Have documented recent progression following or during last treatment, or became intolerant to the last treatment
- Does not have ≥ Grade 2 peripheral neuropathy(PN) prior to receiving Pola
- Patients treated with Pola-BR or Pola-R regimens
Who cannot join
- Patients participating in other clinical studies of Pola.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Jianqiu Wu, Ph.D, +86-13956171579, wujq211@163.com
About this study
Official title: A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin in the Treatment of Patients With Transplantation Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma
To assess the clinical outcomes following treatment with Pola in combination with Bendamustine, Rituximab (BR) or Rituximab (R) in patients with R/R DLBCL who are not eligible for transplantation in the real-world setting.
Read the detailed description
This study is a multi-center retrospective observational study. It aims to evaluate the effectiveness and safety of polatuzumab vedotin treatment in patients with hematopoietic stem cell transplantation ineligible relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), who met the criteria to access Pola through the compassionate use program (CUP). Based on the medical records of patients in the four participating hospitals, the study database will be established by using the unified case report form (CRF) to search extract information the data of target population from the hospital database, that is, the variables without personal identification information.
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- Polatuzumab Vedotin-Piiq
- Keywords
- Diffuse Large B-Cell Lymphoma (DLBCL), Polatuzumab Vedotin
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polatuzumab Vedotin-PiiqDrug
Also called Polatuzumab Vedotin
Patients will receive a total of six cycles of Pola in combination with rituximab and bendamustine or in combination with only rituximab. A cycle is typically 21 days for DLBCL.
| Study group | Role | What they receive |
|---|---|---|
| Pola BR/R | Patients with R/R DLBCL who are enrolled in the Pola CUP program in China, and treated with Pola-BR or Pola-R regimens. Receives: Drug: Polatuzumab Vedotin-Piiq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed best overall response (BOR)
Best overall response (BOR) assessed by the investigator, is based on either PET-CT or CT, and defined as the percentage of patients with CR or PR.
Measured: From the start of the treatment until the date of first documented progression or the completion of the treatment(up to six cycles, each cycle is 21 days)
Secondary outcomes (4)
Objective response rate (ORR)
Objective response rate (ORR) assessed by the investigator at the end of treatment (EOT), is defined as the percentage of patients with CR or PR at the end of treatment.
Measured: At end of the treatment(up to six cycles, each cycle is 21 days)
Duration of response (DOR)
DOR is defined as the time from initial complete response (CR) or partial response (PR) to disease progression, relapse, or death from any cause, whichever occurred first.
Measured: From initial CR or PR to disease progression, relapse, or death from any cause, whichever occurred first, assessed up to 25 months
Complete response (CR)
CR rate is defined as the percentage of patients with CR.
Measured: At end of the treatment(up to six cycles, each cycle is 21 days)
Progression free survival (PFS)
PFS is defined as the time from the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first.
Measured: From the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first,assessed up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start12 Dec 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianqiu Wu, Jiangsu Cancer Institute & Hospital
- Investigators
- Jifeng Feng, Ph.D, Principal investigator, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624893
- Sponsor's protocol ID
- PolaCUP
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin in the Treatment of Patients With Transplantation Ineligible Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04624893
- Acronym / sponsor ID
- PolaCUP
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Keywords
- Diffuse Large B-Cell Lymphoma (DLBCL), Polatuzumab Vedotin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the clinical outcomes following treatment with Pola in combination with Bendamustine, Rituximab (BR) or Rituximab (R) in patients with R/R DLBCL who are not eligible for transplantation in the real-world setting.
Detailed description
This study is a multi-center retrospective observational study. It aims to evaluate the effectiveness and safety of polatuzumab vedotin treatment in patients with hematopoietic stem cell transplantation ineligible relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), who met the criteria to access Pola through the compassionate use program (CUP). Based on the medical records of patients in the four participating hospitals, the study database will be established by using the unified case report form (CRF) to search extract information the data of target population from the hospital database, that is, the variables without personal identification information.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pola BR/R | – | Drug: Polatuzumab Vedotin-PiiqPatients with R/R DLBCL who are enrolled in the Pola CUP program in China, and treated with Pola-BR or Pola-R regimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients enrolled in the Pola CUP program in China
Key inclusion criteria (6 listed)
- Hospitalized patients Patients who enrolled in the Pola CUP program and met the following criteria:
- Histologically confirmed DLBCL, patients have exhausted all therapeutic options for DLBCL and have been treated with at least two prior lines of therapy including R-CHOP (or similar regimen for 1L DLBCL)
- Not considered to be eligible for Bone Marrow Transplantation (BMT) (both allogenic or autologous)
- Have documented recent progression following or during last treatment, or became intolerant to the last treatment
- Does not have ≥ Grade 2 peripheral neuropathy(PN) prior to receiving Pola
Key exclusion criteria (1 listed)
- Patients participating in other clinical studies of Pola.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polatuzumab Vedotin-PiiqAlso: Polatuzumab VedotinPatients will receive a total of six cycles of Pola in combination with rituximab and bendamustine or in combination with only rituximab. A cycle is typically 21 days for DLBCL. | Drug | Pola BR/R |
Primary outcome
Investigator-assessed best overall response (BOR)
Time frame: From the start of the treatment until the date of first documented progression or the completion of the treatment(up to six cycles, each cycle is 21 days)
Best overall response (BOR) assessed by the investigator, is based on either PET-CT or CT, and defined as the percentage of patients with CR or PR.
4 secondary outcomes
Objective response rate (ORR)
Time frame: At end of the treatment(up to six cycles, each cycle is 21 days)
Duration of response (DOR)
Time frame: From initial CR or PR to disease progression, relapse, or death from any cause, whichever occurred first, assessed up to 25 months
Complete response (CR)
Time frame: At end of the treatment(up to six cycles, each cycle is 21 days)
Progression free survival (PFS)
Time frame: From the start of treatment until disease progression, relapse, or death from any cause, whichever occurred first,assessed up to 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jifeng Feng, Ph.D principal investigator
Jiangsu Cancer Institute & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-Cell Lymphoma (DLBCL), run by Jiangsu Cancer Institute & Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianqiu Wu, Ph.D (+86-13951671579, wujq211@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed best overall response (BOR) (time frame: From the start of the treatment until the date of first documented progression or the completion of the treatment(up to six cycles, each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020; AzTrials last refreshed its copy on 2 Nov 2026.